Identity
- Trade Name
- BodyMed FDA UDI
- Generic Name
- Patient monitoring system module, blood pressure, noninvasive FDA UDI
- Device Name
- BODYMED REPLACEMENT BLOOD PRESSURE UNIVERSAL CUFF, 22CM-52CM FDA UDI
- Model / Reference
- ZZABPCUFF FDA UDI
- Description
- BODYMED REPLACEMENT BLOOD PRESSURE UNIVERSAL CUFF, 22CM-52CM FDA UDI
Identifiers
- Catalog Number
- ZZABPCUFF FDA UDI
- Primary DI / UDI-DI
- 00815802014465 FDA UDI
- 510(k) Number
- K131558 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Patient monitoring system module, blood pressure, noninvasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Patient monitoring system module, blood pressure, noninvasive
BodyMed by Boxout, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient monitoring system module, blood pressure, noninvasive.
- Technicuff — Technicuff Corp. · Class II
- Technicuff — Technicuff Corp. · Class II
- ViSi — SOTERA WIRELESS · Class II
- Technicuff — Technicuff Corp. · Class II
- Rite365 — MAYBEAM LLC · Class II
- BOTHEALTH — Shenzhen BSX Technology Electronics Co., Ltd. · Class II
- Finapres — Finapres Medical Systems B.V. · Class II
- MedSource Blood Pressure Unit, Large Adult — MEDSOURCE INTERNATIONAL LLC · Class II
Cleared under the same submission
K131558 also covers:
- Sensiv — Acutens Inc
- BodyMed — BOXOUT, LLC
- JUMAX — JUMAX HEALTHCARE LLC
- Flexmed — RBD GROUP, LLC
- ANKOVO — Shenzhen Lingku Ecommerce Co., Ltd.
- FANRY — Shenzhen Lingku Ecommerce Co., Ltd.
- Metene — Shenzhen Lingku Ecommerce Co., Ltd.
- Metene — Shenzhen Lingku Ecommerce Co., Ltd.
- Electronic Blood Pressure Monitor — Shenzhen Pango Electronic Co., Ltd.
- Electronic Blood Pressure Monitor — Shenzhen Pango Electronic Co., Ltd.
- Electronic Blood Pressure Monitor — Shenzhen Pango Electronic Co., Ltd.
- Electronic Blood Pressure Monitor — Shenzhen Pango Electronic Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boxout, Llc
Sources (1)
- FDA UDI 483002a4-48b5-48d6-b12d-3274f7ac9237 36 fields · synced May 29, 2026